Method of using additive formulation and method for making a tube with an additive formulation
AssigneeBecton, Dickinson and Company
InventorsAntoinette F. Antignani, Emy Cheng, Jeffrey M. Evans, Nicholas A. Grippi, Bryan S. Wong
Life of this patent
Estimating the term…
Abstract
An additive formulation comprising heparinase and trehalose, a method for using the formulation and a device containing the formulation. The additive formulation is useful in substantially neutralizing residual heparin from a blood sample when used in a blood collection tube without interfering with the clinical analysis of the blood sample.
Claims2
A method for eliminating physiological effects of heparin in a mixture of blood components in a blood collection tube having an inner wall, comprising the following steps:
- (a) preparing an additive formulation comprising heparinase, trehalose and a buffer;
- (b) spray coating said additive formulation onto the inner wall of said blood collection tube;
- (c) drying said additive formulation by applying an airjet or forced air to said inner wall of said blood collection tube at about 25 to about 30° C. from about 5 to about 10 minutes;
- (d) vacuum drying said inner wall of said blood collection tube for about 2 hours;
- (e) removing oxygen from said inner wall of said blood collection tube by back flushing said blood collection tube with a gaseous mixture of CO2 and
- (f) stoppering said blood collection tube;
- (g) irradiating said blood collection tube at about 1.5 Mrads;
- (h) adding a blood sample containing heparin into said blood collection tube;
- (i) mixing said blood sample in said blood collection tube by manually inverting said blood collection tube about 5 to 10 times;
- and
- (j) allowing said blood sample to clot.
A method for making a tube with an additive formulation for handling a heparin specimen, comprising the steps of:
- (a) providing a tube having an open end, a closed end, a sidewall extending between said open end and said closed end whereby said sidewall comprises an inner wall surface and an outer wall surface;
- (b) preparing an additive formulation comprising a mixture of sodium phosphate, heparinase, and trehalose;
- (c) dispensing said additive formulation to said inner wall surface of said tube in a fine mist by spraying;
- (d) drying said additive formulation by applying forced air into said tube for about 5 to about 10 minutes to dry said additive formulation on said inner wall surface of said tube;
- (e) vacuum drying said inner wall of said tube for about 2 hours, at about 35° C. and at about 600 millimeters Hg;
- (f) removing oxygen from said tube by back flushing with a gaseous mixture of about 80% CO2 and 20% H2;
- (g) stoppering said tube at said open end;
- and
- (h) irradiating said tube by gamma irradiation.
Dependencies are inferred from the claim text.